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Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction (OMEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841944
Recruitment Status : Unknown
Verified October 2014 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : April 29, 2013
Last Update Posted : April 27, 2015
Sponsor:
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Information provided by (Responsible Party):
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE April 16, 2013
First Posted Date  ICMJE April 29, 2013
Last Update Posted Date April 27, 2015
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Combined total mortality, first event of non-fatal myocardial infarction, stroke and revascularization. [ Time Frame: 24months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01841944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Occurence of new onset atrial fibrillation [ Time Frame: 24months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction
Official Title  ICMJE Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary

The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke and revascularizations with at least 30%.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Myocardial Infarction
  • Heart Failure
  • Myocardial Revascularization
  • Atrial Fibrillation
Intervention  ICMJE
  • Drug: Pikasol
    Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
    Other Names:
    • omega-3
    • polyunsaturated fatty acids
  • Other: Corn oil
    Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer
Study Arms  ICMJE
  • Active Comparator: Pikasol
    Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
    Intervention: Drug: Pikasol
  • Placebo Comparator: Corn oil
    3x capsules of corn oil pr day
    Intervention: Other: Corn oil
Publications * Laake K, Myhre P, Nordby LM, Seljeflot I, Abdelnoor M, Smith P, Tveit A, Arnesen H, Solheim S. Effects of ω3 supplementation in elderly patients with acute myocardial infarction: design of a prospective randomized placebo controlled study. BMC Geriatr. 2014 Jun 13;14:74. doi: 10.1186/1471-2318-14-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
1400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with acute myocardial infarction discharged from hospital alive

Exclusion Criteria:

  • Being part of another randomized trial
  • Documented intolerance for omega-3 fatty acids
  • Additional disease state that is thought to be incompatible with compliance to the study drugs
  • Additional disease state thought to reduce survival for the follow-up time of 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 82 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841944
Other Study ID Numbers  ICMJE 2012/14890
2012-004478-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • University Hospital, Akershus
  • Asker & Baerum Hospital
Investigators  ICMJE
Study Chair: Harald Arnesen, MD Phd Center for Clinical Heart Research
Study Director: Svein Solheim, MD phd Center for Clinical Heart Research
Study Director: Ingebjørg Seljeflot, Phd Center for Clinical Heart Research
Principal Investigator: Kristian Laake, MD Center for Clinical Heart Research
Principal Investigator: Peder Myhre, MD Center for Clinical Heart Research
PRS Account Oslo University Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP